Specialized Workshop M2 - Monday May 06, 2024: 7am to 5:30pm
"AGENDA - Advanced Strategies for Biomarkers and IVD/CDx Assays"
| 07:00am-08:00am: | Start your day at WRIB with Continental Breakfast |
Session 1: Current Challenges in Biomarker Assays Development/BAV: Parallelism, Free Target Measurement, GCLP vs CLIA, New Platforms
Chair: Dr. Danielle Graham, Vice President, Biomarkers and Bioanalysis, Biogen| 08:00am-08:20am: |
Dr. Lindsay King, Senior Director, Biomarker Head, Clinical Bioanalytics,
Translational Clinical Sciences, Pfizer "Parallelism for Biomarker Assays Best Practice" |
| 08:20am-08:40am: |
Mr. Mark Dysinger, Associate Director, Bioanalytical Development, Alexion "Challenges in Development of a High Range Free Target Assay to Support Clinical Studies" |
| 08:40am-09:00am: |
Dr. Kai Wang, Scientific Director, Immunoassay Bioanalysis and Biomarker, GlaxoSmithKline "Immunoassay Biomarker Validation: CLIA vs GCLP" |
| 09:00am-09:20am: |
Mr. Jeff Chen, Associate Director, Bioanalysis & Biomarker Discovery, Astra Zeneca "Expanding the Applications of Olink Proteomics Target Platform in Exploratory Biomarker Studies" |
| 09:20am-09:50am: | Coffee Break with Morning Snacks |
| 09:50am-10:10am: |
Dr. Lindsay King, Senior Director, Biomarker Head, Clinical Bioanalytics,
Translational Clinical Sciences, Pfizer
Mr. Mark Dysinger, Associate Director, Bioanalytical Development, Alexion Dr. Kai Wang, Scientific Director, Immunoassay Bioanalysis and Biomarker, GlaxoSmithKline Mr. Jeff Chen, Associate Director, Bioanalysis & Biomarker Discovery, Astra Zeneca "Panel Discussions on Current Challenges in Biomarker Assays Development/BAV: Parallelism, Free Target Measurement, GCLP vs CLIA, New Platforms " |
Session 2: Vaccine Biomarkers LBA: Focus on Automation, Assay Maintenance/Performance Monitoring and Complex Matrices Development/Validation
Chair: Dr. Jeroen Stoop, Scientific Director, Clinical Microbiology and Immunology, Johnson & Johnson Innovative Medicine| 10:10am-10:30am: |
Dr. Liang Zhu, Director, Immunoassay, Clinical Biomarker Laboratory, Moderna "Automated bioanalysis: strategy, assay qualification and performances in clinical sample testing" |
| 10:30am-10:50am: |
Dr. Rocio Murphy, Senior Director and Head of Global Clinical Immunology, Sanofi "Development and Implementation of a High Throughput, 384-well Automated Platform for Ligand Binding Assays" |
| 10:50am-11:10am: |
Dr. Karl Walravens, Head of Clinical Immunology, GlaxoSmithKline "The maintenance and the monitoring of vaccine immunogenicity assays (VIA)" |
| 11:10am-11:30am: |
Dr. Liang Zhu, Director, Immunoassay, Clinical Biomarker Laboratory, Moderna
Dr. Rocio Murphy, Senior Director and Head of Global Clinical Immunology, Sanofi Dr. Karl Walravens, Head of Clinical Immunology, GlaxoSmithKline "Panel Discussions on Vaccine Biomarkers LBA: Focus on Automation, Assay Maintenance/Performance Monitoring and Complex Matrices Development/Validation " |
Session 3: Mass Spec Assays vs LBA for Measuring Biomarkers and EU IVDR 2017/746 Impact on Global Biomarker Strategy
Chair: Dr. Nicoletta Bivi, Senior Director, CLS Clinical Biomarkers, Lilly| 11:30am-11:50am: |
Dr. Sarah Bond, Senior Director, Bioanalytical Sciences, Alnylam "Biomarker Testing Strategies in Support of RNAi Development" |
| 11:50am-12:50pm: | Sit-down Lunch on the 2nd Floor |
| 12:50pm-01:10pm: |
Dr. Barry Jones, Director, Bioanalysis & Biomarkers, Crinetics "Quantitation of ACTH(1-39), correlation between LC-MS and LBA, and global considerations of biomarker quantitation with mixed context of use." |
| 01:10pm-01:30pm: |
Mr. Brian Baker, Executive Director, IVD Regulatory Affairs, Regeneron "Impact of EU Regulation 2017/746 (IVDR) on Assays used in Drug Clinical Trials" |
| 01:30pm-01:50pm: |
Dr. Sarah Bond, Senior Director, Bioanalytical Sciences, Alnylam
Dr. Barry Jones, Director, Bioanalysis & Biomarkers, Crinetics Mr. Brian Baker, Executive Director, IVD Regulatory Affairs, Regeneron "Panel Discussions on Mass Spec Assays vs LBA for Measuring Biomarkers and EU IVDR 2017/746 Impact on Global Biomarker Strategy " |
Session 4: Development & Fit for Purpose Validation (FFP BAV) of CDx/IVDs: Focus on CDx for AAV- based Gene Therapies (GT)
Chair: Mr. Jad Zoghbi, Scientific Director, Translational Sciences, Biogen| 01:50pm-02:10pm: |
Dr. Agnes Seyda, Director, Translational Sciences & Diagnostics, Bristol Myers Squibb "Precision Medicine at Bristol Myers Squibb: considerations for CDx development" |
| 02:10pm-02:30pm: |
Mr. Michele Fiscella, Vice President Translational & Bioanalytical Sciences, Regenxbio "CDx or no CDx for AAV-based Gene Therapies" |
| 02:30pm-02:50pm: |
Ms. Andrea Van Tuyl, Director, Bioanalysis, BioMarin "Application of a Total Antibody (TAb) Assay as a Companion Diagnostic (CDx) for AAV5 Gene Therapy" |
| 02:50pm-03:20pm: | Coffee Break with Afternoon Snacks |
| 03:20pm-03:40pm: |
Dr. Agnes Seyda, Director, Translational Sciences & Diagnostics, Bristol Myers Squibb
Mr. Michele Fiscella, Vice President Translational & Bioanalytical Sciences, Regenxbio Ms. Andrea Van Tuyl, Director, Bioanalysis, BioMarin "Panel Discussions on Development & Fit for Purpose Validation (FFP BAV) of CDx/IVDs: Focus on CDx for AAV- based Gene Therapies (GT)" |
Session 5: 2024 White Paper in Bioanalysis
| 03:40pm-04:40pm: |
Dr. Danielle Graham, Vice President, Biomarkers and Bioanalysis, Biogen Dr. Jeroen Stoop, Scientific Director, Clinical Microbiology and Immunology, Johnson & Johnson Innovative Medicine Dr. Nicoletta Bivi, Senior Director, CLS Clinical Biomarkers, Lilly Mr. Jad Zoghbi, Scientific Director, Translational Sciences, Biogen "Recommendations on Biomarkers & Companion Diagnostics and Panel Discussions for 2024 White Paper in Bioanalysis" |
Session Finale: ASK THE REGULATORS! Interactive Panel Discussion with All the Regulators
| 04:40pm-05:30pm: |
Regulatory Feedbacks on Submitted Studies and Inspection/Audit Outcomes on Biomarkers & CDx/BAV Regulatory Panelists:
|
| 05:30pm-07:00pm |
Welcome Reception at Marriott Riverwalk Hotel River Terrace / Oak Tree Terrace
|
